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The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative bioavailability of two formulations of BMS-986195 with or without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) | Placebo Comparator | Single ascending dose of BMS-986195 or Placebo matching BMS-986195 |
|
| Multiple Ascending Dose(MAD) | Placebo Comparator | Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 |
|
| Japanese-Multiple Ascending Dose(MAD) | Placebo Comparator | Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage |
|
| Relative Bioavailability with Food Effects (Open Label) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986195 | Drug | Specified dose on specified day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests | Up to 8 days during and after last dose | |
| Safety and tolerability of multiple oral doses of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests | Up to 21 days during and after last dose |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Melbourne | Victoria | 3004 | Australia |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000710709 | branebrutinib |
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| Placebo | Other | Specified dose on specified day |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |